Kyle Peter, Perry Kitrick, Moutadjer Anne, Gilfillan Nicholas, Webb Rosalind, Basak Dolan, Ziprin Paul, Blunt Dominic, Burn James, Van Ree Katherine, Sergot Antoni, Murphy Jamie
Department of Surgery and Cancer, Imperial College London, London, UK.
Imperial College Healthcare NHS Trust, London, UK.
Pleura Peritoneum. 2023 Sep 11;8(4):157-165. doi: 10.1515/pp-2023-0008. eCollection 2023 Dec.
This is the first UK trial of pressurised intraperitoneal aerosolised chemotherapy (PIPAC) for colorectal cancer peritoneal metastases. This trial aimed to assess the impact of PIPAC in combination with standard of care systemic treatment on: progression free survival (PFS); quality of life (QoL); and short-term complications. In addition, this trial set out to demonstrate that PIPAC can be performed safely in operating theatres within a National Health Service (NHS) setting.
Single-centre clinical trial with prospective data collection for patients undergoing 8-weekly PIPAC with oxaliplatin at 92 mg/m from January 2019 till January 2022. Progression free survival was assessed using peritoneal carcinomatosis index (PCI) by CT scans and laparoscopy. Quality of life was assessed by EORTC QLQ-C30 questionnaire. Adverse events were recorded using CTCAE.
Five patients underwent a total of ten PIPAC administrations (median 2, range 1-4). Median PFS was 6.0 months. QoL was maintained across repeat PIPAC procedures but a decrease in social functioning and increased fatigue were evident. Three incidences of grade 3 adverse events occurred but PIPAC was well tolerated.
The presented data demonstrates that PIPAC is feasible and can be safely delivered within the NHS for patients with colorectal cancer peritoneal metastases, but caution must also be exercised given a risk of adverse events. Systemic chemotherapy can be safely administered at a different unit to the PIPAC procedure if both groups have clear lines of communication and timely data sharing.
这是英国首例针对结直肠癌腹膜转移的腹腔内加压雾化化疗(PIPAC)试验。该试验旨在评估PIPAC联合标准护理全身治疗对无进展生存期(PFS)、生活质量(QoL)和短期并发症的影响。此外,该试验还旨在证明PIPAC可在英国国家医疗服务体系(NHS)环境下的手术室中安全进行。
单中心临床试验,前瞻性收集2019年1月至2022年1月期间每8周接受一次92mg/m奥沙利铂PIPAC治疗患者的数据。通过CT扫描和腹腔镜检查使用腹膜癌指数(PCI)评估无进展生存期。通过欧洲癌症研究与治疗组织QLQ-C30问卷评估生活质量。使用CTCAE记录不良事件。
5名患者共接受了10次PIPAC治疗(中位数为2次,范围为1 - 4次)。中位无进展生存期为6.0个月。在重复的PIPAC治疗过程中生活质量得以维持,但社交功能下降和疲劳感增加明显。发生了3例3级不良事件,但PIPAC耐受性良好。
所呈现的数据表明,PIPAC对于结直肠癌腹膜转移患者是可行的,并且可以在NHS环境下安全实施,但鉴于存在不良事件风险,也必须谨慎行事。如果两组有明确的沟通渠道和及时的数据共享,全身化疗可以在与PIPAC手术不同的科室安全进行。